RUral dispaRities in prehospitAL STEMI

Cardiovascular Diseases Clinical Trial

Official title:

RUral dispaRities in prehospitAL STEMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381260
• Other study ID #: IRB00064512
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: June 2, 2022

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Rural Americans are more likely to be unhealthy, older, living in poverty, uninsured, and medically underserved. The CDC has made achieving health equity and improving cardiovascular health for rural Americans one of their Healthy People 2020 overarching goals. ST-Elevation Myocardial Infarction (STEMI) is a life-threatening cardiovascular emergency that frequently affects people without warning within the communities the Participants live and work. Patients with STEMI have a linear relationship between first medical contact to Percutaneous Coronary Intervention (PCI) time and mortality. Delays are particularly important in STEMI patients with cardiogenic shock, who experience an excess 3.3 deaths per 100 for every 10 minute delay to PCI (for PCI times between 60-180 minutes). Delayed PCI is also associated with a higher rate of long term morbidity, including congestive heart failure and repeat MI. Unfortunately, many rural EMS agencies fail to consistently achieve the recommended 90 minute PCI time goal. Rural agencies are less likely than urban/suburban agencies to meet time goals and this disparity exposes rural patients to excess morbidity and mortality. The American College of Cardiology/American Heart Association (ACC/AHA) endorse the need for prehospital strategies to reduce total ischemic time, particularly in rural settings.

Description:

Achieving PCI time goals is influenced by multiple factors, such as patient attributes, agency factors and elements of organizational Emergency Medical Services (EMS) culture. Organizational culture is defined as a set of shared values, beliefs, and assumptions within an organization that influences how people within that organization behave. Differences in organizational culture between hospitals have been associated with both cardiovascular mortality and disease-specific outcomes. Although not yet rigorously studied in the prehospital environment, it is likely that organizational culture contributes to differences in tempo and manner of completing interventions. Prehospital performance accountability and culture have been discussed by experts in EMS magazines but have never been formally studied.

EMS STEMI protocols that include direct transportation to a PCI-capable hospital and pre-hospital PCI center activation improve patient outcomes. Unsuccessful EKG transmission, delayed PCI center activation, and cardiogenic shock have been shown to negatively affect PCI time metrics and patient outcomes. The impact of PCI delays in the rural setting has not been specifically studied. In addition, there are agency-level factors, such as ambulances per capita, number of satellite stations, miles of interstate that likely affect the EMS agency's ability to achieve shorter PCI times for the STEMI patients they care for. This proposal will use mixed methods to identify previously unmeasured components of rural EMS agency organizational culture, structure, care processes, and patient environment that likely influence PCI time and patient outcomes. In addition, this project will identify best practices that can be tested as novel interventions and implemented in rural EMS agencies to improve STEMI time metrics and therefore reduce patient morbidity and mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

STEMI Registry:

Inclusion:

• Age = 18 years

• Transported to one of four primary PCI centers (Wake Forest Baptist Medical Center (WFBMC), High Point Regional Medical Center (HPRMC), Novant Forsyth Medical Center (FMC), and Moses Cone) by rural agency (county identified rural by 2014 Census) ambulance from 2016-2019

• STEMI identified prior to or upon arrival at hospital

Exclusion:

• None

Key Informant Interviews:

Inclusion:

• Rural agency (county identified rural by 2014 Census)

• Identified as the top or bottom two performing services ranked by overall PCI time by regional STEMI registry patients transported to primary PCI center from 2016-2019

• Hold the position of EMS Director, EMS Medical Director, EMS Training Officer, Paramedic (2), EMT Crew Partner (2) or hold a similar key informant position at a local urban EMS agency (Forsyth county EMS) to allow the interview guide to be field-tested

Exclusion:

• None

Stakeholder Survey:

Inclusion:

• Rural agency (county identified rural by 2014 Census) transported to primary PCI center from 2016-2019

• Hold the position of EMS Director, EMS Medical Director, or EMS Training Officer or be a field provider with a Paramedic or EMT certification

Exclusion:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Other:
• No intervention
There is no intervention for patients included in this group as this is a retrospective data registry only.
• Interview
Key Informant Interview
• Survey
Stakeholder survey

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (57)

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* Note: There are 57 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the organizational culture, structure, and clinical processes of high and low performing local rural EMS agencies using qualitative methods	Aim 1 will be accomplished by developing a 2016-2019 STEMI data registry, which will be utilized to identify high- and low-performing rural EMS agencies. After identifying these agencies, Key Informants will participate in interviews designed to assess facilitators and barriers to achieving STEMI time metrics.	1 day
Secondary	Quantify the association between factors identified in Aim 1 and PCI time among rural EMS STEMI patient encounters.	Stakeholder surveys will be utilized to quantify each agency's use of factors identified in Aim 1	1 day

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